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- PMLiVE

Solymbic

Article:

The disparity of patient experiences with Crohn’s Disease in Europe and Japan

Research Partnership

- PMLiVE

Piloting a route to the biosimilars opportunities in Europe

Investigating the EU regulatory hurdles that life sciences companies face as they seek to improve patient access to biosimilar therapy

- PMLiVE

bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Amgen will retain market exclusivity on blockbuster arthritis drug until 2029

- PMLiVE

EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

- PMLiVE

AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

- PMLiVE

Novavax is close to finalising a COVID-19 vaccine supply deal with the EU

Reuters reported that the company is planning to send doses to Europe before the end of the year

EU cross-border healthcare

The clock is ticking to improve access to gene and cell therapies for rare diseases

- PMLiVE

Amgen plans acquisition of Rodeo Therapeutics

Deal could be worth over $700m including potential future milestone payments

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

EU leaders debate COVID-19 vaccine export measures during virtual summit

AstraZeneca urged to ‘honour’ contract with EU before exporting doses elsewhere

- PMLiVE

EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

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